Regulation of borderline disinfectant and related products with antiviral claims including COVID-19

This guidance has been published to assist sponsors and manufacturers of borderline disinfectants and related products that make antiviral claims. Such products often sit at the interface between consumer goods and therapeutic goods.

The COVID-19 pandemic has led to increased enquiries about the regulation of borderline disinfectant and related products with claims that the products can remove, kill or inhibit viruses (such as the virus that causes COVID-19).

Guidance is provided to assist sponsors and manufacturers of a range of borderline products to determine their regulatory obligations, with specific examples provided for clarity. The guidance explains the application of the therapeutic goods legislation for these products, and whether antiviral claims (including in relation to COVID-19) would require the product to be listed or included in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.